AccessGUDID - DEVICE: QT Micro (00854989006078)

GUDID

Device Identifier (DI) Information

Brand Name: QT Micro
Version or Model: Contamination Tester, luer lock outlet
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TM6000
Company Name: Q. I. Medical, Inc.

Primary DI Number: 00854989006078
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 800082950 *Terms of Use

Device Description: TM6000,1 each, 0.22µ Contamination tester, female luer lock inlet, female luer lock outlet. TM6000, case of 10, includes 5cc syringe of TSB Media. TM6001, case of 10, includes 5cc syringe of FTM Media

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
43324	Fluid transfer set, general-purpose	A collection of devices and supplies designed to transfer several types of medical fluids (e.g., drugs, vaccines, blood, and solutions) between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it is not dedicated to a particular type of fluid or clinical procedure. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LHI	Set, I.V. Fluid Transfer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K950305	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: dd5d99f4-40cd-4a3d-8cea-57481f07a1f4
Public Version Date: March 07, 2022
Public Version Number: 5
DI Record Publish Date: March 10, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
10854989006075	200	00854989006078	In Commercial Distribution	Bulk case
00854989006092	10	00854989006078	In Commercial Distribution	Box
00854989006085	10	00854989006078	In Commercial Distribution	Box